TOKYO, May 14 (Pulse News Wire) – Anges,inc. (4563.T) announced today that it successfully held a Type B Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S.
Food and Drug Administration (FDA) regarding its HGF gene therapy product. The meeting was aimed at advancing the Biologics License Application (BLA) submission process for the product. In August 2025, the company had previously disclosed its decision to proceed with BLA preparations following completion of clinical trials for the HGF gene therapy product. In January 2026, AnGes reported positive outcomes from a Type B Clinical Meeting with the FDA concerning clinical aspects of the application.
During the recent CMC meeting, the FDA agreed with AnGes's plans, providing clear guidance for the upcoming BLA submission. Commenting on the progress, President and CEO Yoshihiro Yamada stated, “We feel significant momentum and confidence in our ongoing dialogue with the FDA, which bodes well for further advancements in this program.” Looking ahead, the company intends to disclose additional updates during a pre-BLA meeting scheduled for summer 2026. Notably, there will be no impact on the consolidated earnings due to this meeting. The HGF gene therapy product utilizes plasmid DNA designed to express hepatocyte growth factor (HGF), enhancing blood flow in ischemic areas through the production and secretion of HGF.
This innovative treatment aims to regenerate blood vessels in conditions characterized by poor circulation, offering a novel therapeutic approach developed by AnGes.
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